Comparison of topical travoprost eye drops given once daily and timolol 0.5% given twice daily in patients with open-angle glaucoma or ocular hypertension

Purpose: This 9-month study compared the intraocular pressure (IOP)-lowerin g efficacy and safety of once-daily travoprost ophthalmic solutions (0.0015 % and 0.004%) with twice-daily timolol 0.5%. Patients and Methods: This study was conducted using a double-masked, rando mized, parallel-group designs adult patients with open-angle glaucoma or oc ular hypertension (IOP between 24 and 36 nim Hg, inclusive at 9 Am and betw een 21 and 36 mm Hg, inclusive, at 11 AM and 4 PM on two eligibility visits after an appropriate washout of previous treatments). In both eyes, the tr avoprost vehicle (placebo) was instilled at 9 Am and travoprost (0.0015% or 0.004%) was instilled at 9 Pm, or timolol 0.5% was instilled at both times . The primary efficacy variable was mean IOP measured at 9 AM, I I AM, and 4 Pm at baseline and follow-up visits. Results: Five hundred seventy-three patients were randomized to the study t reatments. Mean IOP, which was combined across study visits, was lower with travoprost 0.004% than with timolol 0.5% at 9 AM (P = 0.0246), 11 AM (P = 0.0039), and 4 Pm (P = 0.0004). Intraocular pressure was lower with travopr ost 0.004% than with travoprost 0.0015% at I I AM (P = 0.0314), the time of peak drug activity. Mean IOP was consistently lower with travoprost 0.0015 % than with timolol 0.5%. Mean IOP reductions from baseline were significan tly (P less than or equal to 0.0001) greater with travoprost 0.004% (8.0-8. 9 mm Hg) than with timolol 0.5% (6.3-7.9 mm Hg). The most frequent related adverse events were hyperemia, pruritus, discomfort, pain, and iris pigment ation changes, The local tolerance was better in the timolol group compared with patients receiving travoprost. There were no serious unexpected treat ment-related adverse events in any group. Conclusions: Travoprost 0.004% reduced diurnal mean intraocular pressure si gnificantly more than timolol 0.5%. Both concentrations of travoprost were well tolerated and safe for use in patients with open-angle glaucoma or ocu lar hypertension.